The Senate health committee, which I chair, held the confirmation hearing the first week in April for Dr. Scott Gottlieb, President Trump’s selection to lead the Food and Drug Administration (FDA).
I am confident Dr. Gottlieb is the right person to lead the FDA given its vital mission. He has impressive qualifications from nearly every perspective – he has served as a practicing physician and hospitalist as well as a former FDA Deputy Commissioner, and he is also a cancer survivor.
The FDA is the agency responsible for making sure that patients benefit from the promising research driven by the 21st Century Cures Act, bipartisan legislation I co-authored that the Senate passed and President Obama signed into law last year. Senate Majority Leader Mitch McConnell called it “the most important piece of legislation” that year.
The reason it was such an important bill is that it will drive forward research and the extraordinary medical miracles that are in the works and that have the potential to affect every American family. Dr. Francis Collins at National Institutes of Health has talked about some of the discoveries that he predicts are possible in the next decade: non-addictive painkillers; hearts rebuilt from our own stem cells; a universal flu vaccine; an HIV/AIDS vaccine; an artificial pancreas for diabetes patients who have spent decades injecting themselves with insulin.
The key to making these miracles a reality is not just investment in research – but a regulatory process that is efficient and effective enough to bring safe discoveries to patients in a timely way.
The FDA has always been important – it’s the agency in charge of assuring the safety and effectiveness of our nation’s medical products and protecting our country’s food supply – but there’s never been a more important time to capitalize on the significant funding Congress has given to medical research.
My hope is that Dr. Gottlieb will help move the agency forward, so that America’s patients benefit from the remarkable discoveries our nation’s researchers are working on.
Our committee is in the middle of its work to reauthorize agreements between the FDA and industry under which drug and device makers pay the agency user fees in exchange for timely reviews.
These user fee agreements are set to expire on September 30. If we do not move quickly to reauthorize these agreements, in late July, the FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days.
The sooner we reauthorize the agreements, the better – to give patients, reviewers, and companies certainty. In addition to harming patients and families that rely on medical innovation, a delay in reauthorizing the user fees would threaten biomedical industry jobs and America’s global leadership in biomedical innovation.
Medical devices are one of Tennessee’s most important exports, and Memphis-area medical devices are the top export of the region.
I look forward to working with my colleagues to approve these agreements here in committee and move them to the floor in a timely manner – so FDA can continue its good work moving drugs and medical devices to patients and doctors’ offices for the patients and families that need them.
LAMAR ALEXANDER (R-Tenn.) is the senior U.S. senator, former Tennessee governor and former U.S. Secretary of Education for 1991-1993. He chairs the Senate Committee on Health, Education, Labor, and Pensions (HELP) and also serves on the Committee on Appropriations, Committee on Energy and Natural Resources and the Committee on Rules and Administration. Alexander may be reached at his Washington, D.C., office at (202) 224-4944 or via his website contact page at alexander.senate.gov.